# FDA 483 - TJA Health LLC - January 29, 2024

Source: https://www.globalkeysolutions.net/records/483/tja-health-llc/64252f43-a445-4090-8d75-34c08f7c8494

> FDA 483 for TJA Health LLC on January 29, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: TJA Health LLC
- Inspection Date: 2024-01-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: TJA Health, LLC, an OTC drug manufacturer in Joliet, IL, was cited for significant deficiencies during an FDA inspection. The observations primarily concern a lack of adequate written procedures, process validation, raw material testing, and quality control investigations. The firm also failed to conduct annual product reviews, establish hold time studies, and perform stability testing for its drug products.

## Related Officers

- [Nibin Varghese](https://www.globalkeysolutions.net/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.globalkeysolutions.net/companies/tja-health-llc/ab3662d3-2668-4193-aa92-7b5f27a36ab7

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766